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Regulatory considerations for biorepositories webinar
 

Regulatory considerations for biorepositories webinar

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In this webinar, we briefly discussed the regulatory considerations for biorepositories including the following: When HHS, FDA and HIPAA regulations apply, When informed consent is not required , Pros ...

In this webinar, we briefly discussed the regulatory considerations for biorepositories including the following: When HHS, FDA and HIPAA regulations apply, When informed consent is not required , Pros and cons of different informed consent approaches

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    Regulatory considerations for biorepositories webinar Regulatory considerations for biorepositories webinar Presentation Transcript

    • Clinical Research Management Webinar Series:Regulatory Considerations forBiorepositories: Navigating HHS, FDA,HIPAA and Informed ConsentWednesday, December 19, 201212:00 p.m. - 1:00 p.m. CT
    • Disclaimer The views expressed in this presentation are the views of the speakers and do not necessarily reflect the views or policies of the companies they represent. This presentation is intended for educational purposes only and does not replace independent professional judgment. Neither Huron Consulting Group or Van Andel Research Institute endorse or approve, and assume responsibility for, the content, accuracy or completeness of the information presented. Attendees should note that sessions are audio-recorded and may be published in various media, including print, audio and video formats without further notice.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 2
    • A Bit About Our Speakers Madeleine Williams Director P 312. 479. 3374 mwilliams@huronconsultinggroup.com Maddie has over 10 years of research experience and assists clients with research biorepository design and development, institutional review board (IRB) assessments and operational support, regulatory compliance evaluations, and human research protection program evaluation and accreditation. Scott Jewell, Ph.D. Deputy Director for Research Resources Professor and Director, Program for Biospecimen Science Van Andel Research Institute P 616. 234. 5435 scott.jewell@vai.org Dr. Jewell is Deputy Director of Research Resources and Professor and Director for the Program of Biospecimen Science at the Van Andel Research Institute. He has served as President of the International Society for Biological and Environmental Repositories (ISBER) and has spent more than 25 years in the collection, banking, distribution and analysis of biospecimens for basic and clinical research.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 3
    • Agenda  Recommended biorepository model  When DHHS, FDA and HIPAA regulations apply  When informed consent is not required  Pros and cons of different informed consent approaches  Q&A / Wrap-up© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 4
    • Regulatory Considerations  Applicable research and privacy regulations • DHHS • FDA • HIPAA • Other state and local laws  Goal should be to set up a biorepository that utilizes the flexibility in the regulations • Appropriate set up for collection and coding of samples and data • Governance model for review and distribution of samples and data to researchers • Work with the IRB to design© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 5
    • Polling Question #1 What kind of biorepository activities are currently ongoing at your institution? a. We have a central biorepository “core” that supports all banking for the institution b. We have a central biorepository but also have decentralized individual investigator biorepositories c. We just have decentralized individual investigator/department biorepositories at our institution d. We only participate in external banking protocols (i.e. cooperative group studies) and send our samples off site e. We do not participate in any biobanking right now f. Not sure what biorepository activities are ongoing© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 6
    • Recommended Biorepository Model Step 2 Step 1 7
    • The Model is a Two-Step Process Step 1: Procedures for collection and banking of specimens Step 2: Procedures for use of specimens Note that “specimens” may be: • Tissue • DNA • Images • Text© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 8
    • The Model Separates the Known and Unknown Activities Oversight must be based on actual uses of specimens Step 1: • Known use: Specimens will be collected and banked for research Step 2: • Unknown uses: Specific research studies that specimens will be used for© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 9
    • Step 1: DHHS and OHRP  OHRP considers the collection of specimens or data for research purposes to be research and guidance recommends that human tissue repositories supported by HHS should be subject to oversight by an Institutional Review Board (IRB).  The IRB should determine if: • The activity is research as defined by the Common Rule • If so, whether the research involves human subjects as defined by the Common RuleOPRR, Issues to Consider in the Research Use of Stored Data or Tissues, November 7, 1997OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 10
    • Step 1: DHHS and OHRP  If the repository involves human research, the IRB should review: • Conditions under which data and samples are collected and shared • Provisions to protect privacy • Provisions to maintain confidentiality of data  OHRP has guidance as to when coded private information or samples are not identifiable so that research on that information does not involve human subjects. • Impact on Step 2 and the need for IRB reviewOPRR, Issues to Consider in the Research Use of Stored Data or Tissues, November 7, 1997OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens, October 16, 2008© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 11
    • Step 1: Other Considerations  Use of an honest broker when collecting identifiable information • An individual, organization or system collects identifiable data and replaces identifiers with a code, and releases only coded information to the researcher or to be stored in the repository. • The honest broker is the only person who can link a subject with the code that identifies that subject. • Useful when collecting and adding long-term follow up data to a repository.  Obtaining a Certificate of Confidentiality for repository samples and data© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 12
    • When is Collection/Storage in Step 1 Not Research? Not all specimen or data collection/storage is research even if specimens are used for research • Pathologic lab archive • Radiology film library • Medical record© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 13
    • When Does Collection/Storage in Step 1 Not Involve Human Subjects? Not all research biorepository storage and collection involves human subjects • Collection of de-identified specimens • Collection of already coded specimens • Collection of autopsy specimens© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 14
    • The Model Minimizes Regulatory Burden Steps 1 and 2 may have different regulatory statuses Step 1: • Usually human research • Usually subject to HIPAA Step 2: (when properly designed) • Usually not human research • Usually not subject to HIPAA© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 15
    • Step 2: Does the research involving human subjects? Both DHHS and FDA regulations may apply. • Systematically consider both. First consider: • Is there “research” as defined by DHHS? • Is there “research” as defined by FDA? If NO to both, stop. (If no research, no human subjects) Then consider: • If DHHS “research” are there DHHS “human subjects”? • If FDA “research” are there FDA “human subjects”?© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 16
    • Human Research Flowchart START Is activity “Human Research” Yes No as defined by DHHS? Is activity “Human Research” Is activity “Human Research” Yes as defined by FDA? No Yes as defined by FDA? No “Human Research” “Human Research” “Human Research” NOT under DHHS and FDA under DHHS only under FDA only “Human Research”© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 17
    • Step 2: Readily Identifiable Information OHRP guidance on biologic specimens and OHRP guidance on engagement provides examples where OHRP considers information to be NOT “readily identifiable”: • The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators • IRB-approved written policies and operating procedures for a repository or data management center prohibit the release of the key to the investigators • Legal requirements prohibit the release of the key to the investigators© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 18
    • Step 2: Coded Samples and Data If the biorepository releases coded samples and data to investigators for specific research studies, in most cases this will not meet the definition of human subjects research Should have appropriate governance structure in place • Scientific committee to review and approve requests for samples/data© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 19
    • Scenario and Polling Question #2  An investigator is conducting research on diabetes. She wants to develop an assay to screen for the presence of a biomarker than is linked with type 2 diabetes. She will obtain blood samples and data from a diabetes repository with no identifying information. She will use these blood samples to develop the assay.  Polling question: Is IRB review required? A. Yes B. No C. Not Sure© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 20
    • Follow Up For Polling Question #2  Yes  FDA considers data regarding the use of a device on human specimens (identified or unidentified) to be a clinical investigation if it will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit  Relevant to specimens: • Individual who serves as a control • An individual on whose specimen a device is used  Important to consider both DHHS and FDA  Scientific review can monitor for this to trigger when IRB review is needed© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 21
    • HIPAA Applies if samples and data are collected within or received by a covered entity Most likely scenarios for repository data, sample labeling: • Identifiable – Authorization from the patient OR – Waiver of authorization from IRB/Privacy Board • Limited Data Set – Data Use Agreement is in place • De-identified (all PHI removed) – If samples are coded to achieve de-identification, HIPAA states that the code may not be derived from or related to the information about the individual and is not otherwise capable of being translated to identify the individual. – For example, the code may not be derived from the individual’s name (i.e. initials), social security number or medical record number.© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 22
    • “De-identified” versus “not readily identifiable” HIPAA defines identifiers that need to be stripped from data to make protected health information de- identified. However, an investigator cannot readily identify the individual from whom the following was obtained: • Zip code • Fingerprints • Dental records© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 23
    • Informed Consent  Human Subject Research Regulations (HHS and FDA) • Informed consent is not required if : 1) the research does not meet the definition of human subjects research under HHS; 2) is exempt from the HHS regulations; 3) the research has been granted a waiver of consent by the IRB; or 4) if the FDA-regulated research involves anonymous tissue specimens where FDA does not require consent (FDA enforcement discretion*)  OHRP Guidance • The IRB should review and approve a sample informed consent document for distribution to tissue collectors and their local IRBs* FDA Guidance, Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, April 25, 2006 © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 24
    • Informed Consent  NCI and ISBER Best Practices • Informed consent information describing the future research should be as specific as possible • Obtain informed consent whenever possible • Consent may be obtained for unspecified future research; mechanisms should be in place to assure that future research uses of identifiable specimens are consistent with the original consent • Subjects should have the right to withdraw consent and to have their unused specimens and data removed from the repository unless the specimens and data are anonymous (no link).© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 25
    • Informed Consent Approaches  General consent for biorepository • Can get consent from subjects to bank specimens (Step 1) and indicate that for future research (Step 2) either their specimens will not be identified, an IRB will waive consent, or their consent will be obtained • Cannot get “blanket” consent from subjects for unspecified future research with identifiable specimens  Tiered consent for biorepository • Subjects can specify the types of research for which their samples/data will be used • Have to be able to track subject choices  Research study specific consent© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 26
    • HIPAA Authorization  A HIPAA authorization may not seek permission to use or disclose PHI for future unspecified research uses of health information.  Authorization can be obtained to create a repository (Step 1) but that authorization does not cover subsequent research uses of identifiable data.  Recommend that data used for future research from the repository (Step 2) be a LDS or de-identified (authorization not required).© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 27
    • Questions?
    • Thank you!For further information, please contact:Madeleine Williams Scott JewellDirector, Huron Consulting Group Van Andel Research InstituteP 312. 479. 3374 P 616. 234. 5435mwilliams@huronconsultinggroup.com scott.jewell@vai.org